There are many forms of orthoses, or devices used externally to modify the structure and/or function of the skeletal and/or neuromuscular systems of the body. For example, there are orthoses that are applied to the neck, to the spine, to the upper limbs, and to the lower limbs. Additionally, there are many different purposes for using orthoses ranging from rehabilitative to prophylactic. Rehabilitation braces are typically used to limit the movement of a portion of the body following an injury or a surgery.
Certain rehabilitation braces, for example orthopedic knee braces, typically immobilize the leg and/or limit the motion in both the lateral and medial directions. These braces provide a mechanism to reduce the range of motion for a healing limb. The ability to limit flexion and extension are important features for an effective orthopedic knee brace. To maximize the benefits of an orthopedic brace it must be properly fitted and adjusted to the patient. Adjustment variables include fitting patients of various sizes and body proportions, and accommodating a variety of possible surgical sites. The adjustment of the brace will also be continual as the patient heals and can tolerate larger ranges of motion, as swelling is reduced, and the like. At times there may also be readjustment of the braces to adapt to accessories and/or product upgrades.
To accomplish the adjustability of the ranges for flexion and extension in existing orthotic braces, some brace designs utilize a system of holes in the hinge plate. For example, in U.S. Pat. No. 7,189,212 a series of holes incorporated into the brace's hinge plate is disclosed. This system of holes allows pin members to be adjusted into a small number of positions in the hinge plate to restrict the patient's range of movement during rehabilitation. The holes disclosed in the aforementioned patent are used with a pair of pins to limit extension and a pair of pins to limit flexion. The pins are retained on the hinge plate by strings and a retaining cover positioned over the hinge plate to prevent loss or unintended movement of the pins. The operator, or physician, must remove the retaining cover from the hinge plate to expose the pins for adjustment of the ranges. Once the pins are exposed, the operator must take out one or more of the four pins and place them into the most appropriate hole(s). Once this is done, the retaining cover must be placed back over the pins and latched closed so the retaining cover will stay in place and prevent the loss and/or movement of the pins.
Similarly, U.S. Pat. No. 5,443,444 discloses a system of holes in the hinge plate to accomplish the adjustability of the ranges for flexion and extension in an orthotic brace. This system of holes allows pin members to be adjusted into a small number of positions in the hinge plate to restrict the patient's range of movement during rehabilitation. The holes disclosed in the aforementioned patent are used with a pair of pins to limit extension and a pair of pins to limit flexion. The pins are retained on the hinge plate using tethers. The tethers are anchored to the hinge plate and a retaining cover is positioned over the hinge plate to prevent the loss and/or unintended movement of the pins. The operator, or physician, must move the retaining cover from the hinge plate to expose the pins for adjustment of the ranges. Once the pins are exposed, the operator must take out one or more of the four pins and place them into the most appropriate hole(s). Once this is done, the retaining cover must be placed back over the pins and latched closed so the retaining cover will stay in place and prevent the loss and/or movement of the pins.
These systems with hinge plates and removable pins are complicated to manufacture and are complicated to use. The removal of a retaining cover exposes the hinge plate and all the inner components of the brace to dust and other debris. Additionally, without the retaining cover the pins could be lost or could inadvertently move, which could cause the patient to be re-injured when they suddenly experience a wider range of motion than is appropriate for their stage in the healing process. In contrast, the flex lock for orthotic braces of the present invention is a cost effective and easy to use mechanism for locking the flexion and extension limits on an orthotic brace.
Other existing orthotic braces accomplish the adjustability of the ranges for flexion and extension by using screws or buttons to adjust and lock the brace in position. For example, PCT Appln. No.: PCT/US84/00336 discloses a single cam-slot mechanism including flexible plungers for simulating the flexural motion of the wearer's limb and a lock for limiting that range of motion. This system includes two set screws, which must be adjusted with a screwdriver to raise and/or lower a set of springs that are in contact with a moveable cam in a slot designed to simulate a patient's range of motion. By turning the set screws, the springs are “set” and the cam in the slot can only move up until the cam meets the springs, thus limiting only the range of motion for flexion.
Similarly, In U.S. Pat. No. 8,425,439 a lock is disclosed for an orthotic brace. The orthotic brace in the aforementioned patent is configured to either 1) move freely with no limit either on flexion or extension or 2) to be locked in a desired fixed position or angle. The lock is comprised of a push-in and turn type of lock that fixes the orthotic brace in a static position. In contrast, the flex lock for an orthotic brace of the present invention allows for quick and easy movement and locking of the brace to control the ranges for both flexion and extension to allow a patient to experience the proper range of motion, which can be adjusted easily by the patient as the patient heals. The flex lock for an orthotic brace of the present invention does not require additional tools (e.g. screwdriver, wire cutters, etc.) or removable parts (e.g. pins, wires, etc.). Furthermore, the flex lock of the present invention provides a mechanism for locking the preferred ranges for flexion and extension.
Other existing orthotic braces accomplish the adjustability of the ranges for flexion and extension by using outwardly biased push buttons that require an external part to “lock” each button in place, once set. See, for example, in U.S. Pat. No. 7,833,181 two buttons are capable of adjusting the flexion and the extension ranges, respectively, but the use of buttons containing holes near the outer ends thereof is required. This system requires a physician or technical assistant to thread a wire or a plastic tie through each of the openings of the buttons to discourage re-setting or tampering with the angular ranges of the brace. Locking or zip ties can also be used. This system is not only cumbersome, but the twisted wire and/or ties can cause scrapes or other injuries to the patient as the ends stick out from the outer surface of the brace hinge. In addition, the mechanism requires the ties to be cut off before the button can be moved. Once the button is moved into the next setting, as the patient is progressing in treatment, another zip tie or wire must be re-threaded through the hole in the push button and twisted to lock the button in place. This is unnecessarily difficult for the patient, but is needed with this system in order to prevent inadvertent re-setting of the brace's angular settings, which could reinjure the patient as discussed above.
One aspect of the present invention is a flexible locking mechanism for use on an orthotic brace. The present invention improves the usability of orthotic braces by providing the user with secure locking mechanism for the angular ranges for both flexion and extension without the need for any tools or any risk of losing components of the brace as in existing orthotic braces. Additionally, the present invention provides a mechanism that ensures that there will not be any inadvertent re-setting of the angular settings, which could re-injure a patient.